BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 4205656 · Received August 19, 2014

    Report

    Report Number
    4205656
    Date Received
    August 19, 2014
    Date of Event
    July 7, 2014
    Report Date
    August 19, 2014
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    IXQ
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT SUSTAINED A DISPLACED VOLAR PLATE FRACTURE AT THE BASE OF THE THIRD DISTAL PHALANX WHEN THE TABLETOP WAS MOVED APPROPRIATELY AT THE COMPLETION OF THE EXAM. THE DESIGN OF THE TABLE DOES NOT PROVIDE FOR HAND SAFETY DURING EXPECTED MOVEMENT OF THE TABLE. OPTIONAL HAND GRIPS ARE AVAILABLE BUT STILL DO NOT FULLY PROTECT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500251 * RADIOGRAPHIC TABLE IXQ CARESTREAM HEALTH, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR UNKNOWN/NOT APPLICABLE